Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-01044-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2013-10-14
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Device technologies australia (dta) in conjunction with the manufacturer, intuitive surgical inc, is informing customers that the incorrect version of the user manual associated with the single-site instruments, specifically the bipolar maryland and curved needle driver instruments, was not distributed to customers prior to shipment and use of the instruments.
  • 조치
    Device Technologies is notifying their customers of the issue. A Device Technologies representative will contact each customer to organise the delivery of the correct User Manual. Customers are requested to discard the previous version once the new User Manual has been received. This action has been closed-out on 10/02/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)Single-Site Bipolar MarylandProduct Code: INS-428080Single-Site Curved Needle DriveProduct Code: INS-428088ARTG Number: 132453, 146826
  • Manufacturer

Manufacturer